A Phase I Study of G3139 Subcutaneous in Solid Tumors

NCT00543231 | Completed Phase 1

• 1 other identifier: GPKS106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. The route of administration limits the convenience of treatment, and catheter-related complications have been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139 administered by subcutaneuous injection.

Conditions

Tumors

Keywords

ECOG; MRT; NCI CTC; SAE; Short Intravenous Infusion to Patients with Solid Tumors

Interventions

G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. Patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids.
• Adequate organ function as determined \< 7 days prior to starting study medication
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• At least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy

You may not qualify if:

• Significant medical diesese
• History of leptomeningeal disease
• Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function.
• Use of any investigational drug within 3 weeks prior to starting study medication
• Known hypersensitivity to phosphorothioate-containing oligonucleotides
• Pregnancy/Lactation

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

Clinical Research Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

oblimersen

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 12, 2007
• Study Start: December 1, 2005
• Study Completion: December 1, 2006
• Last Updated: October 12, 2007

Record last verified: 2005-12

Locations

US (1)